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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K010350
Device Name STA -CALIBRATOR HBPM/LMWH KIT
Applicant
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Applicant Contact ANDREW LOC B. LE
Correspondent
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Correspondent Contact ANDREW LOC B. LE
Regulation Number864.5425
Classification Product Code
GGN  
Date Received02/05/2001
Decision Date 04/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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